Efficacy of nonsolvent flower pollen extracts in healthy women with urinary incontinence: A randomized, double-blind, placebo-controlled, parallel study.

Background: Urinary incontinence (UI) is a debilitating and common condition that adversely affects quality of life. Prescriptive and surgical approaches for managing UI symptoms may result in undesirable risks and complications. This randomized, double-blind, placebo-controlled, parallel study investigated the efficacy of 2 nonsolvent flower pollen extracts on UI in healthy women.

Efficacy of Pea Protein Supplementation in Combination with a Resistance Training Program on Muscle Performance in a Sedentary Adult Population: A Randomized, Comparator-Controlled, Parallel Clinical Trial.

Animal-sourced whey protein (WPr) is the most popular protein supplement among consumers and has been shown to improve muscle mass and strength. However, due to allergies, dietary restrictions/personal choices, and growing demand, alternative protein sources are warranted. Sedentary adults were randomized to pea protein (PPr) or WPr in combination with a weekly resistance training program for 84 days.

Efficacy of a yeast postbiotic on cold/flu symptoms in healthy children: A randomized-controlled trial.

Background: Children attending school/daycare are at high risk of acute respiratory tract infections. EpiCor postbiotic, derived from yeast fermentate, has been demonstrated to improve immune function in adults, reducing the incidence of cold/flu-like or allergy symptoms. As such, studies are warranted in children as available pharmaceutical options have unwanted side effects.

Revisiting the Definition of 'Healthy' Participants in Substantiation of Structure/Function Claims for Dietary Supplements.

Concepts and definitions of 'healthy' have been evolving within clinical treatment algorithms as well as reference standards such as Body Mass Index and Dietary Reference Intakes. Consumers' perception of the word 'healthy' is also changing to reflect longer life span, need to stay active and in a good state of mental well-being while managing multiple diseases. Guidelines from the US Food and Drug Administration indicate that substantiating evidence for support of Structure/Function (S/F) claims for dietary supplements is best derived from clinical research conducted in a 'healthy' population.

Healthy adults supplemented with a nutraceutical formulation containing gel, rosemary and enhances the effect of influenza vaccination in a randomized, triple-blind, placebo-controlled trial.

The study objective was to examine the role of a formulation, UP360, containing rosemary and extracts and gel powder, in healthy adults on supporting immune function with influenza vaccination. A 56-day randomized, triple-blind, placebo-controlled, parallel study consisted of a 28-day pre-vaccination period, an influenza vaccination on Day 28 and a 28-day post-vaccination period. Men and women ages 40-80 who had not yet been vaccinated for the flu were randomized to UP360 or Placebo ( = 25/group).

Bioavailability of calcium in an enriched postbiotic system compared to calcium citrate in healthy postmenopausal females; A randomized, double-blind, comparator-controlled, crossover study.

Introduction: Bioavailability of calcium is an important consideration when designing supplements for achieving adequate calcium intake, mainly in high-risk, and aged populations. Alternative supplementation strategies may be able to circumvent absorption issues commonly seen with calcium supplements. The objective of this study was to assess the bioavailability of a single serving of two calcium formulations vs.

A Randomized, Double-Blind, Placebo-Controlled, Parallel Study Investigating the Efficacy of a Whole Coffee Cherry Extract and Phosphatidylserine Formulation on Cognitive Performance of Healthy Adults with Self-Perceived Memory Problems.

Introduction: Cognition refers to brain functions including memory, learning, and thought processing and is increasingly important to individuals. However, impairment of cognitive function is a concern among North American adults. Therefore, effective and reliable treatments are needed.

Role of and in Enhancing Immune Function Following Influenza Vaccination of Healthy Adults: A Randomized, Triple-Blind, Placebo-Controlled Clinical Trial.

Objective: The study aimed to examine the role of an and formulation, UP446, on supporting immune function in response to influenza vaccination.

Methods: A randomized, triple-blind, placebo-controlled, parallel study consisted of a 56-day intervention period with a 28-day pre-vaccination period, an influenza vaccination on Day 28 and 28-day post-vaccination period. Fifty healthy adults 40-80 years of age who had not received their flu vaccine were randomized to either UP446 or Placebo.

Examining the Systemic Bioavailability of Cannabidiol and Tetrahydrocannabinol from a Novel Transdermal Delivery System in Healthy Adults: A Single-Arm, Open-Label, Exploratory Study.

Introduction: Transdermal cannabinoids may provide better safety and bioavailability profiles compared with other routes of administration. This single-arm, open-label study investigated a novel topical transdermal delivery system on the pharmacokinetics of cannabidiol (CBD) and tetrahydrocannabinol (THC).

Methods: Participants were 39.

Breaking new frontiers: Assessment and re-evaluation of clinical trial design for nutraceuticals.

Despite sophisticated study designs and measurement tools, we have yet to create an innovative space for diet and dietary supplements in the health care system. The path is challenging due to current hierarchies of scientific evidence and regulatory affairs. The role of the randomized, double-blind, placebo-controlled clinical trial (RCT) as a research approach functions well to characterize the benefits and risks of drugs but lacks the sensitivity to capture the efficacy and safety of nutraceuticals.

A randomized, double-blind, placebo-controlled, cross-over pilot study to investigate the efficacy of Rest-ZZZ formula in healthy participants with occasional sleeplessness.

The purpose of this study was to investigate the safety and efficacy of Rest-ZZZ, a natural sleep supplement, in healthy adults without a diagnosed sleep disorder. This randomized, double-blind, placebo-controlled, cross-over study consisted of three 7-day supplementation periods with either Rest-ZZZ, Diphenhydramine (DPH), or Placebo, with a 7-day washout. Twenty-seven participants were randomized to one of three intervention sequences and the Healthy People Sleep Quality Index (HPSQI), Quality of Life (QoL), and Profile of Mood States (POMS) questionnaires were assessed at the beginning and end of each supplementation period.

A Randomized, Triple-Blind, Comparator-Controlled Parallel Study Investigating the Pharmacokinetics of Cannabidiol and Tetrahydrocannabinol in a Novel Delivery System, Solutech, in Association with Cannabis Use History.

An oral route of administration for tetrahydrocannabinol (Δ-THC) and cannabidiol (CBD) eliminates the harmful effects of smoking and has potential for efficacious cannabis delivery for therapeutic and recreational applications. We investigated the pharmacokinetics of CBD, Δ-THC, 11-OH-THC, and 11-nor-9-carboxy-Δ-THC (THC-COOH) in a novel oral delivery system, Solutech™, compared to medium-chain triglyceride-diluted cannabis oil (MCT-oil) in a healthy population. Thirty-two participants were randomized and divided into two study arms employing a comparator-controlled, parallel-study design.

Consuming a Protein and Fiber-Based Supplement Preload Promotes Weight Loss and Alters Metabolic Markers in Overweight Adults in a 12-Week, Randomized, Double-Blind, Placebo-Controlled Trial.

Background: Higher protein and fiber diets promote weight management and metabolic health.

Objectives: This study aimed to determine if greater weight loss and positive changes in metabolic outcomes could be achieved with twice-daily consumption of a high-protein and fiber-based multi-ingredient nutritional shake (HPF) compared with an isocaloric low-protein, lower fiber-based placebo (LPF).

Methods: Study procedures were conducted by an independent research organization under clinicaltrials.

Examining the Efficacy of a Very-Low-Carbohydrate Ketogenic Diet on Cardiovascular Health in Adults with Mildly Elevated Low-Density Lipoprotein Cholesterol in an Open-Label Pilot Study.

The objective of this open-label pilot study was to investigate the efficacy of a very-low-carbohydrate ketogenic diet (VLCKD), known as Nic's Ketogenic Diet, for 140 days on cardiometabolic markers in healthy adults with mildly elevated low-density lipoprotein cholesterol (LDL-C). Study assessments were conducted at Day 0, 28, 56, 70, 84, 112, and 140, and weight and blood pressure (BP) were measured and fasting blood was collected for analysis of plasma lipids. A DEXA scan was performed and body mass index recorded on Day 0, 70, and 140.

Use of a Novel EEG-Based Objective Test, the Cognalyzer, in Quantifying the Strength and Determining the Action Time of Cannabis Psychoactive Effects and Factors that May Influence Them Within an Observational Study Framework.

Introduction: Current methods to detect recent delta-9-tetrahydrocannabinol (THC) use cannot objectively quantify its psychoactive effects (PE). The Cognalyzer, an electroencephalography (EEG)-based method, detects and quantifies the strength of THC-induced PE on a scale from 0 to 100%. This study assesses the relationship between the magnitude of Cognalyzer PE predictions and reported subjective drug effects for 4-h post-cannabis inhalation.

A Randomized, Triple-Blind, Placebo-Controlled, Crossover Study to Investigate the Efficacy of a Single Dose of AlphaWave L-Theanine on Stress in a Healthy Adult Population.

Introduction: Stress is a complex life occurrence essential for survival and goal achievement but can be damaging in excess. Because of the high prevalence of stress in North America, a safe supplement that effectively reduces stress is in demand. The objective of this study was to investigate the efficacy and safety of AlphaWave L-Theanine on whole-scalp and frontal alpha power, midline theta power, and salivary cortisol in healthy, moderately stressed adults.

Sensitivity, Specificity and Accuracy of a Novel EEG-Based Objective Test, the Cognalyzer, in Detecting Cannabis Psychoactive Effects.

Introduction: Current standards for identifying recent cannabis use are based on body fluid testing. The Cognalyzer is a novel electroencephalography (EEG) measurement device and algorithm designed to objectively characterize brainwave alterations associated with cannabis. The objective of this study was to assess the accuracy, sensitivity and specificity levels of the Cognalyzer to characterize brainwave alterations following cannabis inhalation.

Efficacy of and standardised extracts on hot flushes, quality of life, hormone and lipid profile of peri-menopausal and menopausal women: a randomised, placebo-controlled study.

Background: Interest in herbal medicines and non-hormonal therapies for the treatment of menopausal symptoms has increased since the publication of adverse effects of estrogen replacement therapy. Vasomotor symptoms are the most characteristic and notable symptoms of menopause.

Objective: To investigate the changes in the frequency and severity of hot flush and associated vasomotor symptoms experienced by peri-menopausal and menopausal women supplemented with the herbal formulation (Nu-femme™) comprising (SLP+) and (Physta) or placebo.

A randomized, triple-blind, placebo-controlled, parallel study to evaluate the efficacy of a freshwater marine collagen on skin wrinkles and elasticity.

Background: Collagen is the primary component in human skin. With age, there is loss of skin elasticity and collagen, resulting in wrinkle formation and reduction in skin appearance.

Aims: The objective of this randomized, triple-blind, placebo-controlled study was to evaluate the safety and efficacy of a hydrolyzed marine collagen (Vinh Wellness Collagen, VWC) on aspects of skin health and quality in women between 45 and 60 years of age.

Pain Bloc-R Alleviates Unresolved, Non-Pathological Aches and Discomfort in Healthy Adults-A Randomized, Double-Blind, Placebo-Controlled, Crossover Study.

The lack of effective treatment for chronic discomfort without negative side effects highlights the need for alternative treatments. Pain Bloc-R is a natural health product composed of vitamins B, B, D, white willow bark extract, Angelica root extract, acetyl L-carnitine HCl, caffeine, L-theanine, Benfotiamine, and L-tetrahydropalmatine. The objective of this study was to compare the effects of Pain Bloc-R, acetaminophen, and placebo on unresolved aches and discomfort as assessed by the brief pain inventory (BPI) and modified Cornell musculoskeletal discomfort questionnaires.

Efficacy of HA-196 and R0175 in Alleviating Symptoms of Irritable Bowel Syndrome (IBS): A Randomized, Placebo-Controlled Study.

Specific probiotic strains can alleviate the gastrointestinal (GI) symptoms and psychiatric comorbidities of irritable bowel syndrome (IBS). In this randomized, double-blind, placebo-controlled study, the efficacy of HA-196 () and R0175 () in reducing the GI and psychological symptoms of IBS was evaluated in 251 adults with either constipation (IBS-C), diarrhea (IBS-D), or mixed-pattern (IBS-M). Following a 2-week run-in period, participants were randomized to one of three interventions: ( = 84), ( = 83) or placebo ( = 81).

A Whole-Food-Based Health Product (A-F Betafood) Improves Gallbladder Function in Humans at Risk of Gallbladder Insufficiency: A Randomized, Placebo-Controlled Clinical Trial.

A-F Betafood is a whole food-based health product. The product contains phytonutrients and bioactives with antioxidant properties that may support gallbladder and liver function. Herein, we investigated the efficacy of A-F Betafood on gallbladder and liver function.

Effect of a Fermentate on Immune Function in Healthy, Active Adults: A Randomized, Double-Blind, Placebo-Controlled Trial.

produce high amounts of algal β-1,3-glucan, which evoke an immune response when consumed. This study investigated the effect of supplementation with a proprietary fermentate (BG), containing greater than 50% β-1,3-glucan, on immune function as measured by self-reported changes in upper respiratory tract infection (URTI) symptoms. Thirty-four healthy, endurance-trained participants were randomized and received either 367 mg of BG or placebo (PLA) for 90 days.

Vitamin C Bioequivalence from Gummy and Caplet Sources in Healthy Adults: A Randomized-Controlled Trial.

The efficacy of Vitamin C (L-ascorbic acid) supplementation can be assessed by uptake into the blood and retention in leukocytes. Vitafusion® Power C gummy is an alternative vitamin C source which may exhibit similar bioavailability to comparator caplets. The objective of this study was to evaluate the bioequivalence of vitamin C from a vitafusion® Power C gummy formulation and a comparator caplet in healthy adults.

A Randomized, Double-blind, Placebo-controlled, Parallel Study Evaluating the Efficacy of Bacillus subtilis MB40 to Reduce Abdominal Discomfort, Gas, and Bloating.

Introduction: Bloating is a common yet poorly managed complaint among healthy people, with a complex etiology that impacts health and general well-being. The study intended to evaluate the efficacy and safety of supplementation with a probiotic, Bacillus subtilis MB40 (MB40), on bloating, abdominal discomfort, and gas in healthy participants.

Methods: In this multi-center, double-blind, placebo-controlled, parallel trial, 100 participants were randomized to receive either MB40 at 5 × 109 colony forming units (CFU; n = 50) or a placebo (n = 50) once daily for 4-weeks.